MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK FEMORAL-RM-LL-SZ 8; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number	180518
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
As reported: when going to implant the femur component the surgeon stated that when the posterior post went in the anterior post would not fixate into the hole.Tried multiple times when cementing component in and it would not seat into the post holes correctly.Please note that the trial 8 rm femur fit into place perfectly on the first try.We confirmed post holes were completely burred and there were no issues with array movement throughout the case.Another 8 rm femur implant was opened and cemented into place with no issues with the post holes seating.Pka case delayed 5 minutes.
Event or Problem Description
As reported: when going to implant the femur component the surgeon stated that when the posterior post went in the anterior post would not fixate into the hole.Tried multiple times when cementing component in and it would not seat into the post holes correctly.Please note that the trial 8 rm femur fit into place perfectly on the first try.We confirmed post holes were completely burred and there were no issues with array movement throughout the case.Another 8 rm femur implant was opened and cemented into place with no issues with the post holes seating.Pka case delayed 5 minutes.
Additional Manufacturer Narrative
An event regarding a fit issue involving a mako femoral component was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection: visual inspection of the device shows "damage consistent with attempted implantation/explantation".Dimensional inspection: a dimensional inspection of the device was performed.The device was deemed to be within spec.Full results of the inspection are attached.Functional inspection: not performed as the failure mode could not be recreated.Material analysis: material analysis is not performed as this is not related to material integrity.Damage consistent with attempted implantation/explantation.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.

• Brand Name: MCK FEMORAL-RM-LL-SZ 8
• Common Device Name: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7671332
• Report Number: 3005985723-2018-00409
• Device Sequence Number: 2644078
• Product Code: NPJ
• UDI-Device Identifier: 00848486000677
• UDI-Public: 00848486000677
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K090763
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 180518
• Device Lot Number: 2356221-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR